Status:
NOT_YET_RECRUITING
Safety and Efficacy of ZVS203e in the Treatment of Retinitis Pigmentosa Caused by RHO Gene Mutation
Lead Sponsor:
Chigenovo Co., Ltd
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This trial employs a single-arm, open-label seamless Phase I/II design, consisting of two stages: Phase I dose exploration and Phase II dose expansion.The primary objective of this trial is to evaluat...
Detailed Description
ZVS203e injection is administered via a single subretinal injection of rAAV8 vector carrying CRISPR/Cas9 gene-editing tools to silence mutated genes, allowing retinal cells to express only normal func...
Eligibility Criteria
Inclusion
- Patients with a clinical diagnosis of retinitis pigmentosa (RP) (aged 18 years or older);
- RHO (c.403C\>T, p.R135W) gene site-specific mutation was confirmed by genetic testing, and no other ophthalmic genetic diseases were complicated;
- The researchers judged that the target eye had viable retinal photoreceptor cells and retinal pigment epithelial cells;
- The best corrected visual acuity of the target eye is between 2.0 LogMAR and 0.5 LogMAR (including 2.0 LogMAR and 0.5 LogMAR, which is equivalent to a number of fingers to 60 letters);
- The subject and his or her spouse agree to use effective contraception during the trial period and for at least 1 year after dosing;
- Voluntarily participate in clinical trials and sign informed consent, and can complete the whole test process according to the protocol requirements.
Exclusion
- The researcher determined that the target eye currently has or had macular lesions such as macular hiatal hole or macular neovascularization;
- Have other eye conditions that may prevent surgery or interfere with interpretation of the study endpoint, such as glaucoma, diabetic retinopathy, eye or periocular infections, active endophthalmitis, etc.
- Within 3 months prior to enrollment, the study eye had received any intraocular surgery, such as phacoemulsification cataract extraction.
- The study eye had undergone retinal reattachment or vitrectomy.
- Participants who had participated in any drug or medical device clinical trial within 3 months before enrollment;
- Previously treatment of either eye with gene therapy or stem cell therapy for RP and other ocular diseases, including but not limited to viral vector gene therapy, RNA therapy.
- Treatment with medications that may affect the efficacy and safety evaluation of the investigational product within 3 months prior to enrollment (e.g., ranibizumab, bevacizumab, aflibercept, conbercept).
- Known allergy to the drug planned to be used in the study.
Key Trial Info
Start Date :
May 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 18 2045
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06952842
Start Date
May 18 2025
End Date
June 18 2045
Last Update
May 1 2025
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191